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Phase 2 N=19 Randomized Treatment

Effectiveness of an Opioid Sparing Pain Regimen in Cardiac Surgery

Pain, Postoperative

Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: The Number of Patients With Requests for Breakthrough Opioid Pain Medication in Opioid Standard of Care Regimen Compared to Non-opioid Multimodal Pain Relief Regimen (Experimental Group). — 7; 2; 7; 1 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Oral Gabapentin and Intravenous Acetaminophen (IV APAP) (Drug); Opiate based pain regimen. (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Inova Health Care Services
Primary completion
Jul 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
The Number of Patients With Requests for Breakthrough Opioid Pain Medication in Opioid Standard of Care Regimen Compared to Non-opioid Multimodal Pain Relief Regimen (Experimental Group).
7; 2; 7; 1; 1; 1
PRIMARY
Average Pain Score at 24, 48 and 72 Hours Post-operatively
1; 0.09; 7; 3.18; 1; 0.18
SECONDARY
Number of Participants With Ileus During Hospitalization
0; 0

Summary

The Inova Heart and Vascular Institute (IHVI) perform over 300 coronary artery bypass graft (CABG) surgeries per year. While opioid medications are the institutional standard of care for post-operative pain therapy little is known about the variation in pain scores, incidence of post- operative complications, and cost of hospitalization when an alternative multimodal pain regimen consisting of oral Gabapentin and intravenous Acetaminophen (IV APAP) is utilized. The objective is to determine whether there is a substantial difference in pain scores, incidence of post-operative complications, and costs associated with hospitalization when a non-opioid multimodal pain regimen is utilized A single- center, open label, prospective, randomized, controlled clinical trial comprised of 20 total patients who have undergone isolated CABG at the IHVI will be conducted. Separate cohorts will include patients receiving opioid medications post-operatively (Group 1) and patients receiving the non-opioid regimen of oral Gabapentin and IV APAP (Group 2) to be followed for 72 hours post CABG surgery. Main outcome measures include pain scores in both study groups, requests for breakthrough pain medication in both groups, gastrointestinal and respiratory complications of ileus and reduction in tidal volumes or forced vital capacity (FVC) at baseline and at 72 hours,increase in serum AST/ALT, and comparison of cost of hospitalization between groups. The objective of this pilot study is to provide evidence that multimodal pain therapy utilizing IV APAP and PO Gabapentin will provide more effective pain relief than standard of care opioids as evidenced by pain scores <2. And the reduced consumption of opioids will lead to a reduction in ileus, no increase in AST/ALT, post-operative tidal volumes as assessed by incentive spirometry comparable to pre- surgical values, while also showing a positive effect on the cost of hospitalization.

Eligibility Criteria

Inclusion Criteria

  • Patient between 18 and 85 years old.
  • Elective or urgent surgery requiring sternotomy approach
  • Subject is able to read and has signed and dated the informed consent document including authorization permitting release of personal health information (PHI) approved by the Inova Institutional Review Board (IRB).

Exclusion Criteria

  • Patients lacking enteral access on post-operative day 0
  • Inability to communicate
  • Active chronic pain with opioid therapy
  • Active chronic use of gabapentin or pregabalin
  • Active substance abuse
  • Current self- report of alcoholism
  • End stage renal disease
  • Active renal dialysis therapy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03679013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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